Kornimate/medical-research-clean huggingface dataset:
le as a marker for periprosthetic joint infection

Conditions: Prosthetic-joint Infection

Summary: testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test

the primary objective of this study is to assess the equivalence of a semi-quantitative electrochemical leukocyte esterase test system and off-label use of the roche chemstrip leukocyte esterase (le) test for the diagnosis of periprosthetic joint infection (pji) in synovial fluid from hip and knee joints. in this study, the qualitative outcome of each of the two methodologies for detecting leukocyte esterase enzyme will be compared. the hypothesis of this study is that the two tests will demonstrate equivalence. the leukocyte esterase enzyme level will also be compared to synovial white blood cell count, which will be considered as a secondary reference.

Eligibility criteria:
inclusion criteria: 1. age greater than 18 years 2. willing and able to sign the informed consent document 3. subjects presenting with presumed aseptic failure of a prosthetic joint and expected to undergo revision arthroplasty, or subjects presenting with presumed pji and expected to undergo either dair or radical implant resection, and subjects being investigated for pji having joint aspiration outside of the operating room who may or may not require surgical intervention. exclusion criteria: 1. subjects with known active crystalline deposition disease (e.g. gout) 2. subjects with adverse local tissue reaction (altr) as a result of corrosion of components or metal-on-metal bearing surface in the hip 3. subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis) 4. subjects undergoing a second-stage re-implantation procedure for pji 5. subjects in which standard of care assessments, at a minimum serology (esr and crp) and synovial fluid analysis (synovial wbc count, neutrophil percentage, and culture), cannot be performed. 6. subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.
assess efficacy & safety of selumetinib in combination with docetaxel in patients receiving 2nd line treatment for v-ki-ras2 kirsten rat sarcoma viral oncogene homolog (kras) positive nsclc

Conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Summary: the purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic nsclcs that harbor mutations of kras. this study will also assess the pk, safety, patient reported outcomes (pro) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

a phase iii, double-blind, randomised, placebo-controlled study to assess the efficacy and safety of selumetinib (azd6244; arry-142886) (hyd-sulfate) in combination with docetaxel, in patients receiving second line treatment for kras mutation-positive locally advanced or metastatic non small cell lung cancer (stage iiib - iv) (select-1)

Eligibility criteria:
inclusion criteria: * provision of signed, written and dated informed consent prior to any study specific procedures * male or female, aged 18 years or older * histological or cytological confirmation of locally advanced or metastatic nsclc (iiib-iv) * kras mutation positive tumour sample as determined by the designated testing laboratory * failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy exclusion criteria: * mixed small cell and non-small cell lung cancer histology. * received \>1 prior anti-cancer drug regimen for advanced or metastatic nsclc. patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible. * receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment * other concomitant anti-cancer therapy agents excepts steroids * prior treatment with a mitogen-activated protein kinase (mek) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable). * last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

Keywords: mitogen-activated protein kinase kinase inhibitor; non small cell lung cancer; metastatic; second line treatment for non small cell lung cancer; kras mutation
effect of crp and saa point-of-care testing on antibiotic prescribing for acute respiratory-tract infections

Conditions: Antibiotic Prescribing for Acute Respiratory-tract Infections

Summary: the study was a practical, cluster-randomized controlled trial to evaluate the impact of crp and saa point-of-care testing (crp\&saa poct) on antibiotic prescribing in patients with acute respiratory-tract infections (ari) at primary care facilities in rural china.

the study was a practical, cluster-randomized controlled trial to evaluate the impact of crp and saa point-of-care testing (crp\&saa poct) on antibiotic prescribing in patients with acute respiratory-tract infections (ari) at primary care facilities in rural china. the study includes two arms, in which crp\&saa poct will be provided in 20 village clinics in the intervention arm. additional physician training on the use of crp\&saa poct (including centralized training, distribution of physician training manuals, and desk reminders) and patient education sheets (to help patients understand the help of crp\&saa poct in guiding their care) will also be provided；the control arm will not receive any intervention and will serve as the control (usual care). the primary outcome is the proportion of patients who are diagnosed with aris and prescribed antibiotics during their initial visit (defined as no prescription record at the current institution within the preceding 14 days) in both study arms.

Eligibility criteria:
eligibility criteria for clusters village clinics with an annual outpatient volume exceeding 2000, an average of 10 or more patients per week presenting with aris, and licensed prescribers are considered eligible for selection for the intervention. annual outpatient prescriptions and average weekly visits for aris will be verified by obtaining prescription data from all village clinics for the previous year, as documented in the information section of the local health board. eligibility criteria for participants the target population of this study included (1) patients of all ages diagnosed by a village doctor with aris (including upper and lower respiratory infections); and (2) patients who present with ≥1 acute respiratory symptoms (including cough, rhinitis (sneezing, nasal congestion or runny nose), sore throat, shortness of breath, wheezing or abnormal auscultation). patients with non-respiratory diseases or those with severe clinical symptoms requiring referral to a higher-level institution are excluded from the target population.

Keywords: point-of-care testing acute respiratory-tract infections primary care facilities antibiotic prescription
the aortic surgery cerebral protection evaluation (ace) randomized cardiolink-3 trial

Conditions: Aortic Aneurysm, Thoracic

Summary: the ace trial is a multicentre, randomized controlled trial comparing axillary vs. innominate artery cannulation for established antegrade cerebral perfusion in patients having aortic surgery (thoracic and aortic arch) requiring deep hypothermic circulatory arrest using a non-inferiority trial design.

surgery on the thoracic aorta often requires a brief period of deep hypothermic circulatory arrest (dhca). the most feared complication of aortic surgery is neurological injury, which can range from mild cognitive impairment to more severe injuries such as stroke. due to the significant morbidity and mortality associated with post-operative stroke and neurological dysfunction, cerebral protection techniques have evolved extensively. a recommended approach to cerebral protection during dhca is to deliver blood to the brain in an antegrade fashion via the arterial system, so called antegrade cerebral perfusion (acp). axillary artery cannulation, a form of acp, has become the preferred method of neuroprotection for aortic operations requiring dhca. however, axillary artery cannulation requires more surgical time and presents potential complications such as brachial plexus injury, seromas, and limb ischemia. the present study aims to determine whether a less common alternative strategy, innominate artery cannulation, offers similar neuroprotection compared to axillary artery cannulation and reduces operative times. a total of 110 patients undergoing elective aortic surgery will be randomly assigned to one of the two strategies. the primary outcome will be the number of patients with new ischemic lesions found on post-operative diffusion weighted mri (dw-mri) and total operative time.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. elective aortic arch operation. 3. planned open distal anastamosis with deep hypothermic circulatory arrest. exclusion criteria: 1. patients undergoing surgery for aortic dissection or urgent/emergent operation. 2. patients undergoing surgery for total aortic arch replacement. 3. patients who are unable to undergo mri scan (such as due to claustrophobia). 4. use of an investigational drug or device at the time of enrolment 5. participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes

Keywords: antegrade cerebral perfusion innominate artery cannulation axillary artery cannulation aortic surgery deep hypothermic circulatory arrest
diagnostic performance assessment of qualitative ifobt and quantitative ifobt for advanced neoplastic

Conditions: Colorectal Neoplasms

Summary: in argentina, there is vast experience in qualitative ifobt population screening that is part of the crc prevention and early detection national program. the screening's cut-off point is at 50 ng/ml buffer. its positivity rate for 2019 has been an average of 26.15%, over the double of the one reported in the international literature (7.5-11%) for this cut-off point (1). there are no studies that assess such technology and suggest an appropriate cut-off point for this population. the goal of this study is to assess the diagnostic performance of the qualitative ifobt used in the present and the quantitative ifobt with various cut-off points for advanced neoplastic wound screening (colorectal cancer and advanced adenoma) in an argentine patient cohort.


Eligibility criteria:
inclusion criteria: * men and women aged 50-75 * hospital el cruce's coverage area and exclusion criteria: * those that have taken part in a previous vcc screening in the 5 past years or in a crc screening program the year before the recruitment * personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60 * those refuse to sign the consent form to take part in this study

Keywords: screening colorectal cancer fecal immunochemical test fit accuracy
efficacy of intensified transcranial direct current stimulation in obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Symptom

Summary: this is a randomized, double-blind, parallel-group, sham-controlled trial that aims to investigate the effectiveness of transcranial direct current stimulation (tdcs) on improving symptoms, quality of life, depression, and cognitive functions in 39 patients with obsessive-compulsive disorder (ocd) that are randomized in 3 experimental groups.


Eligibility criteria:
inclusion criteria: * diagnosis of obsessive-compulsive disorder by a psychiatrist and dsm-5-based behavioral checklist * being 18-50 years old * providing written informed consent * if female, negative urine pregnancy test * stable medication regime especially the classical neuroleptics and all cns-activating medications, if taken, 4-6 weeks before the experiment and during the experiment exclusion criteria: * smoker * pregnancy * alcohol or substance dependence * history of seizure * history of neurological disorder * history of head injury * presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.
incretin-based therapy in preclinical type 1 diabetes in adults

Conditions: Type 1 Diabetes

Summary: the main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.


Eligibility criteria:
inclusion criteria: * 18-30 years of age * positive for at least 2 biochemical islet autoantibodies * have normal glucose tolerance in ogtt * are not pregnant exclusion criteria: * allergic to liraglutide or other ingredients of victoza® * type 1 diabetes * diabetic ketoacidosis * previous treatment in the last three months with any antidiabetic medication * impaired liver or kidney function or on dialysis * severe heart failure * severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease * past or current history of pancreatitis * serum calcitonin value above normal (\>50 ng/l or ≥3.4pmol/l) * presence of any chronic metabolic, hematologic or malignant disease * obesity bmi ≥30 * pregnant females and females of childbearing potential who are not using adequate contraceptive methods. * breast-feeding

Keywords: diabetes type 1 diabetes, insulin-dependent liraglutide preclinical type 1 diabetes glp-1 analogue
triglyceride-glucose index in heart failure patients in sohag university hospital

Conditions: Heart Failure; Insulin Resistance

Summary: study the relationship between triglyceride glucose index and heart failure patients


Eligibility criteria:
inclusion criteria: * all heart failure patients attend to sohag university hospital aged above 18 year old . exclusion criteria: * patients on lipid lowering medications * patients on antidiabetic drugs * patients with comorbidities eg liver cirrhosis or malignancy

Keywords: heart failure triglyceride-glucose index
enlighten: an adaptive technology weight loss intervention

Conditions: Obesity; Weight Loss

Summary: the enlighten study is an 8-week trial investigating the response to use of a smartphone diet and activity application. participants are enrolled as part of a worksite intervention, and will receive the loseit! weight loss smartphone application, which requires participants to self-monitor dietary intake and physical activity, a component shown to effectively produce weight loss. the application will be programmed to deliver dietary intake recommendations during the first three weeks of the intervention. at the 3 week time point, self-monitoring adherence via the smartphone application will be assessed and those who are not responding will receive 4 weekly telephone coaching sessions. those individuals who respond at the end of 3 weeks will be encouraged to continue self-monitoring on the application. all participants will also receive regular text messages throughout the trial. the importance of the proposed research lies in the objective to reconfigure weight loss treatment so as to achieve the intended outcome more efficiently and in a manner that allows greater reach.


Eligibility criteria:
inclusion criteria: * bmi greater than 25-39.9 kg/m2 * weigh no more than 300 pounds. * weight stable (no loss or gain \>25 lbs for the past 6 months) * not enrolled in any formal weight loss program * not currently taking anti-obesity medications * interested in losing weight * own an android smartphone or iphone, be willing to install the lose it! application, and agree to join the enlighten group which will allow study staff to view participant data using a private coaching interface. exclusion criteria: * unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months) * history of diabetes requiring insulin supplementation * crohn's disease * diagnosis of obstructive sleep apnea requiring intervention (i.e. cpap) * require use of an assistive device for mobility (e.g., wheelchair, walker, cane) * bmi greater than or equal to 40, weight greater than or equal to 300 pounds * hospitalization for a psychiatric disorder within the past 5 years * those at risk for adverse cardiovascular (cvd) events with moderate intensity activity * those who cannot read the study questionnaires will be excluded * those currently taking weight loss medication or committed to following an incompatible dietary regimen. * female participants may not be pregnant, trying to get pregnant, or lactating. * bulimia nervosa * binge eating disorder * active suicidal ideation * those on medications known to cause weight gain (e.g., prednisone) * current substance abuse or dependence besides nicotine dependence * low motivation to change that would interfere with program adherence
determination of ustekinumab levels in patients with crohn's disease

Conditions: Crohn Disease

Summary: observational, prospective, single-center follow-up study carried out with patients from the area of the virgen de macarena university hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

prospective follow-up observational study carried out with patients from the virgen de macarena university hospital, under treatment with ustekinumab in the induction and maintenance phase in order to determine the cut-off points of the ustekinumab levels between which a clinical remission is expected in patients with inflammatory bowel disease.

Eligibility criteria:
inclusion criteria: * over 18 years. * patients treated with ustekinumab in induction and maintenance phase. * they must agree to participate in the clinical study, having previously signed the informed consent. exclusion criteria: * any patient who does not meet the inclusion criteria previously described and / or who refuses to participate in the study.
high vs. low segmental hysterotomy: impact on uterine wall defects post-cesarean

Conditions: Placenta Accreta Spectrum

Summary: the purpose of this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar (niche) and surgical complications when using high-segment versus low-segment hysterotomy, with both cross-suturing and non-cross-suturing techniques, in pregnant patients undergoing their first cesarean section. researchers will compare four arms: * low segment hysterotomy + crossed hysterorrhaphy * high segment hysterotomy + crossed hysterorrhaphy * low segment hysterotomy + non-crossed hysterorrhaphy * high segment hysterotomy + non-crossed hysterorrhaphy participants will: * cesarean delivery * attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography.

this study will be conducted as a single-blind trial. patients will be approached in the delivery room, where a comprehensive review of the inclusion and exclusion criteria checklist will be conducted to determine their eligibility for the study. once eligible patients are identified, the study will be thoroughly explained to them, highlighting its purpose, potential benefits, and risks. this will be followed by a detailed discussion of the informed consent form to ensure that participants fully understand what their involvement entails. upon obtaining informed consent, a randomization process will be implemented to allocate participants to one of the four study arms. the assigned procedure will be performed by their attending gynecologist, who is familiar with their medical history and care needs. throughout the study, various outcomes will be measured, including intraoperative findings, postoperative recovery, and post-discharge progress. a transvaginal pelvic ultrasound will be ordered to be performed between 6 and 16 weeks postoperatively. during the single follow-up appointment, this imaging evaluation will be carried out to determine the presence or absence of an isthmocele, as well as to assess its characteristics, such as size and location, if present.

Eligibility criteria:
inclusion criteria: * pregnant women aged ≥ 18 years. * confirmed pregnancy through clinical history or ultrasound between 36 and 42 weeks of gestation. * indication by the attending gynecologist for a first cesarean section, either emergent or elective. exclusion criteria: * history of myometrial intervention, such as myomectomy. * history of genetic or acquired conditions that alter the anatomy of the uterus. * history of coagulation disorders. * history of connective tissue disorders, such as lupus and scleroderma, which may affect healing. * hemodynamically unstable patients due to a clinical condition prior to performing the cesarean section. * failure to sign the informed consent.

Keywords: high segmental hysterotomy low segmental hysterotomy caesarean section hysterotomy defects
randomized trial for optimal number of passes required for molecular profiling during eus-fnb of pancreatic cancer

Conditions: Pancreatic Cancer; Pancreatic Neoplasms; Adenocarcinoma of the Pancreas

Summary: this is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer

endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. by using novel fine needle biopsy (fnb) needles during eus-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of \>90%. molecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. as the procurement of core tissue is possible with eus-fnb, adequate tissue can now be obtained for molecular profiling. however, the number of passes required during eus-fnb to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice. the primary aim of this study is therefore to elucidate the optimal number of passes required during eus-fnb to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.

Eligibility criteria:
inclusion criteria: 1. age 18 years and over 2. suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy exclusion criteria: 1. age \< 18 years 2. females who are pregnant 3. pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound 4. biopsied pancreatic mass is not adenocarcinoma on pathology